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For professionals in the regulatory affairs field, RAPS’ annual Regulatory Convergence is one of the most important events of the year. For those speaking, the event holds even more significance. We spoke to a handful of presenters from the recent 2016 Convergence in San Jose, CA.

Nicole Landreville, PEng, RAC, FRAPS

2016 Session Presented: Regulatory Strategy Forum for Medical DevicesPresenter Bio: With a combined 19 years of RA experience, Nicole Landreville is always more than happy to share her knowledge with her RAPS peers. Landreville joined GE Healthcare RA team in 2007. All through the first five years of her career at GE Healthcare, she provided regulatory affairs guidance to design teams in the preparation of premarket submissions and management of market approvals for multiple products designed for global markets. Subsequently, Landreville joined the GEHC global regulatory intelligence team where she focused on requirement flow down activities for three years. Currently, Landreville takes great pride in RA program management for the GEHC Women’s Health Team providing RA strategy planning and implementation for bone densitometers and mammography systems.

Why did you decide to speak at Convergence?Very early in my career, I took the opportunity to attend multiple RAPS conferences where I met several RAPS speakers from the industry and from regulators that really impressed me with the quality of their Regulatory Affairs presentations. Regulatory Affairs can be extremely boring unless you can feel the passion in the voice of speakers. In 2001, I was asked by Don Boyer, RAPS incoming chair of the RAPS Board of Directors, to fill in for him during a speaking engagement about Canada Medical Device Regulations. I remember being so excited (and also very nervous) about it, but I knew I could only improve my public speaking skills by jumping in with both feet and follow my heart. As my RA knowledge increased, my public speaking skills also improved with practice, and I ended up getting involved as an RA speaker for the many years to come.About three years ago, I received a call from RAPS asking me to fill-in for someone and to speak at a preconference workshop on regulatory strategy planning. At that time, I had given multiple training sessions, I had worked on several regulatory strategy plans and had gained expertise in regulatory intelligence. So from an expertise standpoint, I felt I was ready to tackle a bigger challenge. To my surprise, RAPS asked me to chair the program. I accepted and with my excellent faculty team members, we continuously work hard together to make this program a continuing success.

What were you hoping to get out of speaking?When I speak, I always hope to share what I know and to learn from others. I present on a regular basis regulatory updates, which allows me to stay up to date with the current ever changing regulations. When I present, I have this incredible desire to engage the whole room because I believe this is the best way for participants to learn. For instance, the regulatory strategy program requires participants to think and to interact. This specific program is not about giving lectures as much as it is about engaging the group to work and interact with each other and with our faculty members.Putting together such a session is challenging. Sometimes I wonder “should I be spending so much time and energy on this?” It is draining, especially when we already work over 50 hours a week for our regular job. I am not complaining here, I absolutely adore my job. But then, after each and every annual program, our students tell us the impact our program had on them and on their career development and that is simply the so rewarding that we all agree to do it again next year. In speaking, I seek the satisfaction that comes from knowing I have made a positive impact on someone’s career. Plus, I feel that speaking allows me to shape the development of future RA speakers. People will watch our presentation style and learn from it, in the same way I do. Our presentation content and style evolves and it is very important to listen to the participant’s feedback to adjust our content and our style.Another huge benefit is that when I speak I make a lot of connections. Each year, attending RAPS and speaking results in a positive expansion of my network. When our pre-conference program ends, the annual conference begins and it’s interesting to see how many of the participants will hang out during the entire rest of the conference.

2016 Regulatory Strategy Forum for Medical Devices Session Group

Did your experience match your hopes and expectations?RAPS did a great job this year; I feel it was a fantastic Convergence! As always, the takeaways from sessions and networking opportunities were tremendously impactful. Overall, I am so glad I decided to take on this project and to stick with it for 3 years in a row. Keeping the program information up to date helps my presentation team keep our knowledge base current. We are always learning as we develop the course and the case studies. I believe the program keeps getting better and better each year as we take attendee’s feedback to heart and we use it to improve.This year we did something a little different, and asked our group to go out for a social event on Saturday night. We had a great time, and created lasting friendships. The connections I make by chairing this program seem to last. I have program alumni reaching out to me, telling me “this is the best pre-conference I have been to! Can I get the case studies from this year?” There are always so many positive comments. I feel like I grow more and more every year because of this experience, but I also can see how I have a direct hand in growing the profession. I might be working long hours, but it is so worth it at the end of the day.

At what point in someone’s career would you encourage them to apply to speak at Convergence?I have seen a wide variety of RA speakers. If someone is comfortable with their topic and they are eager to share their knowledge with their RA peers, I don’t see a reason why they couldn’t start presenting early in their career. I don’t believe the number of years working in the industry is a show stopper. A 20-minute presentation is very doable for someone early in their career as long as they have the desire to do so. In my opinion, the earlier you start speaking, the earlier you can build your public speaking skills and your confidence.That said, the speaker’ interest level, the speaker’s organizational skills and depth of knowledge of the topic is probably more important than the presentation skills of the speaker. Leaving attendees with good information is crucial. Speakers need to be focused on what they can provide, asking them “what do I want the audience to take away from my speech?”

Do you have any advice for anyone thinking about speaking at Convergence?If you are interested in speaking at Convergence, don’t let the size of the event intimidate you. Picking a topic you feel passionate about will help you. If you feel uncomfortable speaking in public, I can assure you that you can learn to be a better and more comfortable speaker through good preparation and speaking practice. Feedback on your presentation is invaluable to improving your delivery and building your confidence.My advice to you is to follow a process to develop your presentation in an organized fashion. Decide what you want to convey, structure your topics into blocks, allocate the necessary time to each so you can convey the message comfortably and think about how to best deliver the message you want to deliver: presentation aid such as concise PowerPoint slides, incorporate visuals – graphs, tables, pictures. Prepare what you want to say and don’t plan to read slides! No one likes to hear someone read slides. The best speakers don’t read their slides. Instead, they engage their audiences, they make people think and they encourage them to ask questions. In my experience, well-prepared interactive presentations are very memorable for the audience.People come to Convergence because they have questions, and they are very active. The questions in our program tend to be involved and spread across a variety of topics. As a speaker, you don’t need to know everything, that’s impossible. Simply let people know you don’t know, ask the audience if they know and then confirm you will try to find out and get back to them with the answers.Regarding your possible stage fright… Speaking in front of a room of RA Professionals can be nerve racking. The day before I leave for Convergence, I’m always a very anxious about how things will go. Don’t limit yourself because of this nervousness or because you are shy. Those are emotions that can be better controlled with practice. Keep your eyes on the prize – the rewards of speaking are incredible! Every time I give a presentation and share what I know, I feel happy… As Lori Hartwell clearly stated during this year’s Convergence keynote, the secret of happiness is to give! Not only is Lori very inspirational but she is right!

Do you have what it takes to present at RAPS Regulatory Convergence? We are accepting proposals on topics and ideas for our 2018 Convergence here!